On January 15th, the U.S. Court of Appeals for the D.C. Circuit overturned a district court grant of summary judgment for plaintiff tobacco companies Lorillard Tobacco and R.J. Reynolds in favor of the FDA and anti-tobacco co-defendants. This amounted to a win for IPR’s client, the American Thoracic Society (ATS). On behalf of ATS and jointly with the Campaign for Tobacco Free Kids, IPR had submitted an amicus brief in support of FDA.
The dispute centered on a report by the twelve-member Tobacco Products Scientific Advisory Committee (TPSAC)—commissioned by the FDA—concerning the safety of menthol cigarettes. The report showed similar rates of lung cancer and other diseases in menthol smokers compared to other cigarette smokers, and discussed the disproportionately high use of menthol cigarettes in young people and African Americans. The overarching recommendation of the report was hardly forceful; TPSAC merely stated that “[r]emoval of menthol cigarettes from the marketplace would benefit public health in the United States.”
Nonetheless, the tobacco companies brought suit alleging that three members of TPSAC had been unlawfully appointed in violation of conflict-of-interest statutes and regulations, essentially biasing the menthol report and leading to stricter regulation of menthol cigarettes by FDA. FDA countered with standing and merits arguments, asserting the members were not conflicted out and the menthol report was lawful.
In a July 2014 ruling, the district court agreed with the tobacco companies, and ordered TPSAC membership to be reconstituted and enjoined FDA use of the menthol report. The FDA promptly appealed to the D.C. Circuit.
In the amicus brief, IPR’s staff attorney Justin Gundlach and student attorney Nathalie Prescott laid out the policy implications of the district court’s decision. In particular, the brief discussed FDA’s extensive background dealing with conflict-of-interest laws, the judiciary’s historical deference to agency conflict determinations, and the potentially wide-reaching ramifications of highly qualified experts becoming discouraged from serving on advisory committees.
After reviewing the briefs and hearing oral argument, D.C. Circuit vacated the district court’s summary judgment decision on ripeness grounds. According to the appellate court, FDA has yet to issue a final rule on menthol cigarettes, making the tobacco companies’ claims of injury “insufficiently imminent.” Even more, FDA does not have to make a rule based on the menthol report – it only has to consider the report, along with the public comments allowed under the Administrative Procedure Act. Because FDA may well choose not to issue any rule at all, the suit is not ripe.
Because the D.C. Circuit dismissed on the basis of ripeness, it did not review the merits of the case, which were the focus of IPR’s amicus brief arguments.
Former IPR student Nathalie Prescott drafted this post.